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Renal Protocol Protection in CKD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04024514
Recruitment Status : Active, not recruiting
First Posted : July 18, 2019
Last Update Posted : March 31, 2023
Sponsor:
Information provided by (Responsible Party):
Jeong Min Lee, Seoul National University Hospital

Study Description
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Brief Summary:
This study aims to investigate whether acceptable image quality is achievable using low contrast media dose and low keV imaging in chronic kidney disease.

Condition or disease Intervention/treatment Phase
HCC CKD Other: low dose CT contrast media Other: Standard dose CT contrast media Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Development of Renal Protection Protocol Using Low Dose Contrast Media and Spectral Computed Tomography in Chronic Kidney Disease Patients
Actual Study Start Date : December 24, 2019
Actual Primary Completion Date : December 11, 2020
Estimated Study Completion Date : September 30, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Low dose
Low CT contrast media dose
 Other: low dose CT contrast media
CT contrast media (Ioversol 320mgI/kg) is administrated at a dose of 300mgI/kg in low dose group
Active Comparator: Standard dose
Standard CT contrast media dose
 Other: Standard dose CT contrast media
CT contrast media (Ioversol 350mgI/kg) is administrated at a dose of 525mgI/kg in standard dose group.


Outcome Measures
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Primary Outcome Measures :
  1. Overall image quality [ Time Frame: 6 months after complete enrollment ]
    qualitative scoring for image quality on five-point scale (1: worst, 5: excellent, representative value is average score)


Secondary Outcome Measures :
  1. Contrast media (CM) dose [ Time Frame: 3 months after complete enrollment ]
    administered CM dose in each group

  2. Incidence of Contrast media-induced nephrotoxicity [ Time Frame: 3 days after contrast media administration ]
    serum Cr level increase by 25% or more of the baseline, or 0.5mg/dl in 3 days after contrast media administration without other cause

  3. Image contrast [ Time Frame: 12 months after complete enrollment ]
    qualitative scoring for image contrast on five-point scale (1: worst, 5: excellent, representative value is average score)

  4. Lesion conspicuity [ Time Frame: 12 months after complete enrollment ]
    qualitative scoring for focal lesion depiction on five-point scale

  5. lesion (HCC) detection [ Time Frame: 12 months after complete enrollment ]
    detection rate of focal liver lesion/HCC on CT


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • High risk group for developing HCC
  • Scheduled contrast-enhanced CT for HCC diagnosis or surveillance
  • chronic kidney disease (Estimated GFR < 60mL/min/1.73m2)

Exclusion Criteria:

  • not a high risk group for developing HCC
  • congestive hepatopathy
  • on dialysis
  • no venous access on forearm
  • anticipated beam hardening artifact due to prosthesis
  • relative/absolute contra-indication of contrast-enhanced CT except CKD (Estimated GFR < 60mL/min/1.73m2)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04024514


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jeong Min Lee, MD Seoul National University Hospital
More Information
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Responsible Party: Jeong Min Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04024514    
Other Study ID Numbers: SNUH-2019-0343
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: March 31, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeong Min Lee, Seoul National University Hospital:
CT
Spectral